Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters. [ Time Frame: 48 hours after admission until 5 days after discharged from the PICU ]

The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.

Measure Description

No text entered.

Time Frame

48 hours after admission until 5 days after discharged from the PICU

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.

Measured Values

Daily Nutriceutical Supplementation

Whey Protein

Number of Participants Analyzed
[units: participants]

149

144

The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.
[units: Days]Median ( 95% Confidence Interval )

12.1
( 9.25 to 32.4 )

13.2
( 10.8 to NA )
[1]

[1]

The upper limit of the 95% confidence interval for median number of days to event in this arm is not calculable due to an insufficient number of participants reaching the event at the final time point for assessment.

Statistical Analysis 1 for The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.

Groups [1]

All groups

Method [2]

Log Rank

P Value [3]

0.29

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).

[2]

Other relevant method information, such as adjustments or degrees of freedom:

Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: